A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy

Exclusion Criteria

• •1. The participant has active multiple primary cancers, (synchronous multiple primary cancer or metachronous multiple primary cancer with the disease-free survival ≤ 5 years)
• •2. The participant has received surgical castration.
• •3. The participant has ever received LHRH agonists other than commercially available 1-month or 3-month depot of leuprolide acetate.
• •4. The participant has ever received LHRH antagonists.
• •5. Patients who have previously received estrogen preparations or corticosteroids for prostate cancer
• •6. Patients who have previously received chemotherapy for prostate cancer
• •7. Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) or the marketed products for 1 month (LEUPLIN FOR INJECTION 3.75 and KIT 3.75) as an adjuvant therapy after prostatectomy and/or radiotherapy
• •8. Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) for intermittent androgen deprivation therapy
• •9. Patients who received the following drugs within 24 weeks (168 days) after starting the study drug: Steroidal antiandrogens, type II 5α-reductase inhibitors
• •10. The participant received any of the following within 16 weeks (112 days) prior to study enrollment:
• •（1） Radiotherapy. As for I-125 brachytherapy, within 35 weeks (245 days) prior to study enrollment.
• •（2） Prostatectomy （3） Experimental therapy including high-intensity focused ultrasound therapy (HIFU), immunotherapy, and gene therapy 11. Patients who received the following drugs within 4 weeks (28 days) before starting the study drug: Testosterones, ketoconazole（except for external preparations）, spironolactone, corticosteroids (excluding their inhalants and external preparations), and Chinese medicines and dietary supplements containing saw palmetto 12. Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening 13. The participant has a history of hypersensitivity to synthetic LHRH, LHRH derivative or any component of the study drug.
• •14\. The participant has central nervous system metastasis which requires treatment or which is symptomatic.
• •15\. The participant already has a history or has a complication or may have renal disorder caused by spinal cord compression or ureteric obstruction.
• •16\. The participant has a history of serious drug allergic reaction/hypersensitivity 17. The participant has a history of, or has been diagnosed with thromboembolism including myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or cardiac failure